Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Cysts

Kidney Diseases

Kidney Diseases, Cystic

Pathological Conditions, Anatomical

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

220 participants will be included in the active surveillance group. Active surveillance is close monitoring (every 6 months the first 3 years following diagnosis and annually the following years), done per standard of care Close monitoring include: abdominal imaging (ultrasound, CT or MRI), chest X-ray or CT scan and blood tests

110 participants will be included in the surgery group. Surgery is done per standard of care. The type of surgery is at the discretion of the treating physician and may include: partial resection, total resection, thermoablation.

Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)

Active surveillance

Per standard of care: partial or full resection of the kidney, imaging annually

Surgery

Amelie Tetu

Lora Mendoza

Bimal Bhindi

Stacey Broomfield

Lucas Dean, MD

Kelly MacDonald

Dani Clegg

Ricardo Rendon, MD

Marie Therese Balart

Rahul Bansal, MD

David Yachnin

Luke Lavallee

Shalyn Littlefield

Walid Shahrour, MD

Thisun Saram

Antonio Finelli

Rachel Gutschon

Philippe Violette, MD

Estel Duquet-Deblois

Matthieu Gratton

Amal Nadiri

Jean-Baptiste Lattouf

Samara Bloom

Nawar Hanna, MD

Rodrigo Skowronski

Simon Tanguay

Marilyn Savard

Frédéric Pouliot

Elsie Morneau

Patrick O Richard

Kate O'Connor

Miles Mannas, MD

Solène Ricard

Jean-Christophe Bernhard, MD

Patrick O Richard, MD,MSc,FRCSC

One third of individuals aged \>60 years will be diagnosed with at least one renal cyst following abdominal imaging. These cystic lesions are categorized according to the Bosniak classification which categorizes cysts according to their degree of complexity and risk of malignancy. Growing evidence suggests that a significant proportion of Bosniak III and IV cysts are benign and that the malignant ones present low metastatic potential. Since renal surgery carries substantial morbidity (20%) and potential mortality (0.5%), active surveillance has gained attention as a potential tradeoff to surgery to overcome overtreatment. Therefore, prospective studies of long-term follow-up are needed to confirm the oncologic safety of this strategy for patients with Bosniak III/IV cysts.

This is an multicenter prospective observational longitudinal study. The main objective is to compare the 5-year follow-up cancer-specific survival between the active surveillance and the surgical groups.

Background: One in three patients over 60 years old will be diagnosed with a renal cyst following abdominal imaging. Traditionally, experts have recommended that complex cystic lesions (also known as Bosniak III - IV cysts) should be surgically removed, but recent evidences suggest that many are benign or have low metastatic potential. Thus, active surveillance which involves close follow-up of a patient's condition, was proposed as a tradeoff option to surgery.

Design: Multicenter observational longitudinal prospective cohort study

Objectives: The goal of this multicenter project is to conduct a prospective study with a 5-year follow-up to confirm the oncologic outcomes of active surveillance in the management of complex cysts. The main objectives are: 1) to compare the 5-year cancer specific survival between cysts managed by surgery and active surveillance; 2) to evaluate disease progression; 3) to evaluate patient's well-being according to each management strategy; and 4) to compare the 5-year healthcare cost of both management approaches.

Study population: Patients incidentally diagnosed with a Bosniak III and/or IV cysts, who are deemed to have at least 5 years of life, and who opted to be managed by either surgery or active surveillance. (N=330)

Follow-up: Patients will DECIDE if they want to have a surgery or to be followed by active surveillance. All patients will be followed as per standard of care with either semi-annual and annual visits. Research visits will serve to assess vital status and quality of life scores (through validated questionnaires). Patients on active surveillance will also be assessed for cyst progression and might be offered invasive or systemic therapy if progression is observed.

Surveillance of Complex Renal Cysts - The SOCRATIC Study

Predictive ability of radiomics (comparison between imaging and clinical/research data)

Defined as kidney cancer survival 5 years after the enrollment

Defined as survival 5 years after enrollment

Defined as survival 2 years after enrollment

Defined as kidney cancer survival 2 years after the enrollment

Defined as survival without treatment (in active surveillance group)

Defined as the number of people who discontinued active surveillance at the end of the study (over the total)

Defined by change in volume (cm3 ) and change in maximal diameter measured over time (years). Volume will be calculated using the formula for ellipsoid volume: 0.5326 x length x width x height.

Defined as the percentage of patients with tumors that have met our pre-specified progression endpoints

Defined as the time from the date of enrollment to the date where an individual experienced tumor progression or censoring due to lost to follow-up or the end of follow-up period

Defined as demographic (i.e. age, sex, comorbidities, medical history, etc) and tumor characteristics (i.e. tumor size, tumor complexity, etc) associated with kidney cancer deaths

Defined as demographic (i.e. age, sex, comorbidities, medical history, etc) and tumor characteristics (i.e. tumor size, tumor complexity, etc) associated with disease progression.

Defined as the change in EQ5D-5L scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).

Defined as the change in short form health survey (SF-12) scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).

Defined as the change in Hospital Anxiety and Depression Scale (HADS) scores over time (enrollment to censoring due to lost of follow-up or the end of follow-up period).

Defined as the total direct (patients) and indirect (healthcare system) cost associated with the management of a complex cyst according to each treatment strategy (active surveillance and surgery).

Spots Global Cancer Trial Database for complex renal cyst